Get the free NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMP...
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This document alerts high dose rate afterloader licensees to a safety defect involving GammaMed 12i bronchial catheter clamping adapters, recommending discontinuation of their use until replacements
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How to fill out nrc information notice 95-50
How to fill out NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS
01
Read the NRC INFORMATION NOTICE 95-50 in its entirety to understand the context and details.
02
Identify the specific section that pertains to the GAMMAMED 12i bronchial catheter clamping adapters.
03
Gather all relevant information related to the usage and distribution of the GAMMAMED 12i devices in your facility.
04
Complete the required notification form included in the notice, ensuring accuracy in all provided information.
05
Submit the form to the designated NRC office listed in the notice, adhering to the specified deadlines.
06
Maintain a copy of the completed form and all correspondence for your records.
Who needs NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
01
Healthcare facilities that utilize GAMMAMED 12i bronchial catheter clamping adapters.
02
Radiation safety officers responsible for compliance with NRC regulations.
03
Clinicians and staff involved in the administration of procedures using the GAMMAMED 12i devices.
04
Medical device manufacturers or suppliers associated with the product.
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What is NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
NRC INFORMATION NOTICE 95-50 addresses a safety defect in the Gammamed 12i bronchial catheter clamping adapters, identifying the risks associated with their use and advising manufacturers and users on safety measures.
Who is required to file NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
Manufacturers, distributors, and users of the Gammamed 12i bronchial catheter clamping adapters are required to file the NRC information in response to the safety defect notice.
How to fill out NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
To fill out NRC INFORMATION NOTICE 95-50, stakeholders must provide specific details about the affected products, including serial numbers, the extent of the defects, corrective actions taken, and any adverse effects experienced.
What is the purpose of NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
The purpose of NRC INFORMATION NOTICE 95-50 is to inform relevant parties about the identified safety defects, prompt communication regarding potential risks, and outline corrective actions to ensure patient safety.
What information must be reported on NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL CATHETER CLAMPING ADAPTERS?
The information that must be reported includes the identification of the defect, descriptions of incidents related to the defect, corrective actions that were taken or planned, and any communications sent to customers regarding the defect.
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